Use of protamine sulfate during transfemoral transcatheter aortic valve implantation – a preliminary assessment of administration rate and impact on complications

Abstract

Introduction Bleeding complications after transcatheter aortic valve implantation (TAVI) are an important issue and negatively affect survival. The rate and impact of protamine sulfate (PS) administration on bleeding complications after TAVI remain unclear. Aim To assess the impact of PS on bleeding complications after TAVI. Material and methods Between March 2010 and November 2016 two hundred fifty-eight patients qualified for TAVI in one academic center were screened. Baseline, procedural and follow-up data up to 30 days were collected and analyzed. The primary endpoint (PE) was major bleeding according to the Valve Academic Research Consortium up to 48 h after the procedure. Results Overall, 186 patients (96 females, mean age: 80 years) met the inclusion criteria. Thirty-nine (21%) subjects received PS. PE occurred in 24.7% of the study population. There were no significant differences in terms of the PE rate between the groups (25.6% in the PS group and 24.7% in the remaining cohort, p = 0.9, odds ratio (OR) = 1.05, confidence interval (CI): 0.47–2.4, p = 0.9). Multivariate analysis identified female gender (OR = 2.2, CI: 1.08–4.4, p = 0.03) as an independent predictor of PE occurrence. Similarly, female gender (OR = 2, CI: 1.06–3.84, p = 0.03) as well as general anesthesia (GA, OR = 2.23, CI: 1.13–4.63, p = 0.02) and dose of unfractionated heparin per kilogram (UFH/kg, OR = 1.02, CI: 1–1.03 per 1 IU increment, p = 0.02) predicted the occurrence of a composite of major and minor bleeding. Conclusions In this analysis, PS administration did not decrease the PE rate. Female gender predicted PE occurrence. Randomized, placebo-controlled trials are required to accurately assess the impact of PS.

Protamine sulfate during transcatheter aortic valve implantation (PS TAVI) — a single-center, single-blind, randomized placebo-controlled trial

“…Only 2 published papers focused on protamine sulfate administration after TAVI. In a recently published retrospective analysis of our own material (186 patients undergoing transfemoral TAVI, 44% via surgical cut-down, 21% received PS at operators' discretion) PS administration did not decrease the rate of bleeding complications [15]. Conversely, in a much larger (873 patients), single-center, prospective observational study, in which 677 patients undergoing TAVI received PS, protamine administration resulted in significantly lower rates of life-threatening and major bleeding complications while not increasing the occurrence of stroke and myocardial infarction [16].…”

“…The median age was 82 years (IQR 77-85), there were 48 males (48%), almost 90% of patients had hypertension, 43% -diabetes, and approximately one-third (36%) was in New York Heart Association (NYHA) class III or IV. The median logistic EuroSCORE was 10.5 (IQR,(8)(9)(10)(11)(12)(13)(14)(15)(16). All the procedures were performed via transfemoral access and in all cases, a pre-close system was used.…”

Computed tomography guided tailored approach to transfemoral access in patients undergoing transcatheter aortic valve implantation

“…What was different in the current study, to achieve hemostasis in the PA group, two Proglides with additional Angio-Seal and administration of protamine sulphate were used. An appropriate dose adjusted to the heparin dose was administered at the end of the procedure to reverse unfractionated heparin and achieve potential benefits in reducing bleeding complications [ 19 ]. The present study showed a lower incidence of all bleeding complications (12.2% vs. 28.6%) associated with the access site in the PA with additional Angio-Seal compared to closure with two Proglides solely, but still with a higher incidence than in the SA group [ 20 – 22 ].…”

Evolving concepts in the management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation

“…Although subclinical leaflet thrombosis was lower with apixaban compared with antiplatelet therapy, this did not lead to an improvement in clinical outcomes [56,57]. In fact, in line with the results of GALILEO (8), more non-cardiovascular deaths occurred in the apixaban group as compared to the antiplatelet group [51]. In contrary to GALILEO and ATLANTIS, cohort A of the POPular TAVI trial (n=690) investigated a deescalated antithrombotic strategy and randomized patients to aspirin monotherapy versus three months of aspirin plus clopidogrel, followed by aspirin alone [10,58].…”

“…Furthermore, unfractionated heparin can be reversed using protamine sulphate in order to reduce bleeding complications. This has been adopted from its use in cardiac surgery and is supported by low-level evidence [49][50][51]. One retrospective study (n=873) reported that heparin reversal by protamine administration resulted in significantly lower rates of life-threatening and major bleeding complications compared with patients without heparin reversal.…”